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Title:
REFERENCE SYSTEM FOR DYNAMIC IMPLANT NAVIGATION AND KIT THEREFOR
Document Type and Number:
WIPO Patent Application WO/2017/072653
Kind Code:
A1
Abstract:
The reference system (1) for the implant dynamic navigation, comprising at least an intraoral reference (2, 24, 25) arranged in correspondence of an anatomical portion (3) to be treated inside the oral cavity (4) of a patient, an anchoring device (5) fixed to the anatomical portion (3) and an extraoral reference (6) locked together with said anchoring device (5), wherein the intraoral reference (2, 24, 25) comprises at least one of: - a compound (7, 8) applied in correspondence of at least three distinct points of the anatomical portion (3), wherein the compound (7, 8) comprises a tissue marker (7) and a contrast agent (8) trappable radiologically; - an adhesive strip (9) applied to the anatomical portion (3) and having at least three distinct and spaced apart containment seats for a contrast agent (8) trappable radiologically; - a plurality of rings (24) applied in correspondence of at least three distinct points of the anatomical portion (3) and composed at least in part of a contrast material trappable radiologically.

Inventors:
MARCHESI MARCELLO (IT)
Application Number:
PCT/IB2016/056398
Publication Date:
May 04, 2017
Filing Date:
October 25, 2016
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
MARCHESI MARCELLO (IT)
International Classes:
A61C8/00; A61B34/20; A61B90/00; A61C1/08; A61C9/00
Foreign References:
US20130131505A12013-05-23
US20040127824A12004-07-01
US8172573B22012-05-08
DE19902273A12000-08-03
Attorney, Agent or Firm:
GRANA, Daniele (IT)
Download PDF:
Claims:
CLAIMS

1) Reference system (1) for the implant dynamic navigation, comprising at least an intraoral reference (2, 24, 25) arranged in correspondence of at least one anatomical portion (3) to be treated inside the oral cavity (4) of a patient, at least an anchoring device (5) fixed to said anatomical portion (3) and at least an extraoral reference (6) locked together with said anchoring device (5), characterized in that said intraoral reference (2, 24, 25) comprises at least one of:

- at least one compound (7, 8) applied in correspondence of at least three distinct points of said anatomical portion (3), wherein said compound (7,

8) comprises at least one tissue marker (7) and at least one contrast agent (8) trappable radiologically;

- at least one adhesive strip (9) applied to said anatomical portion (3) and having at least three distinct and spaced apart containment seats for at least one contrast agent (8) trappable radiologically;

- a plurality of rings (24) applied in correspondence of at least three distinct points of said anatomical portion (3) and composed at least in part of a contrast material trappable radiologically.

2) System (1) according to claim 1, characterized in that said compound (7, 8) is inoculated in correspondence of said three points of the anatomical portion (3) to be treated.

3) System (1) according to claim 1, characterized in that said rings (24) are made of a polymeric material and/or of a metal material.

4) System (1) according to claims 1 or 3, characterized in that each of said rings (24) comprises at least one portion with an adhesive layer.

5) System (1) according to one or more of claims 1, 3 and 4, characterized in that said intraoral reference (2, 24, 25) comprises a plurality of indelible marks (25) formed directly on said anatomical portion (3) through holes on said rings (24).

6) System (1) according to one or more of the preceding claims, characterized in that said anchoring device (5) comprises at least one arc (11) made of a deformable material. 7) System (1) according to one or more of the preceding claims, characterized in that said anchoring device (5) comprises at least three fastening elements (16) associable with said anatomical portion (3).

8) System (1) according to one or more of the preceding claims, characterized in that said anchoring device (5) comprises at least one holding element (12) of said extraoral reference element (6).

9) Kit (5, 6, 9, 19) for the preparation of a reference system (1) for the implant dynamic navigation, comprising:

at least one anchoring device (5) fixable to at least one anatomical portion (3) to be treated inside the oral cavity (4) of a patient;

at least an extraoral reference (6) associable with said anchoring device (5); characterized in that it comprises at least one of:

at least one medical injector device (19) containing at least one tissue marker (7) and at least one contrast agent (8) trappable radiologically, able to be inoculated in correspondence of at least three distinct points of said anatomical portion (3) to be treated ;

at least one adhesive strip (9) applicable to said anatomical portion (3) and having at least three distinct and spaced apart containment seats for at least one contrast agent (8) trappable radiologically;

- a plurality of rings (24) applicable in correspondence of at least three distinct points of said anatomical portion (3) and composed at least in part of a contrast material trappable radiologically.

10) Kit (5, 6, 9, 19) according to claim 9, characterized in that said rings (24) are made of a polymeric material and/or of a metal material.

11) Kit (5, 6, 9, 19) according to one or more of claims 9 and 10, characterized in that each of said rings (24) comprises at least one portion with an adhesive layer.

12) Kit (5, 6, 9, 19) according to one or more of claims 9 to 11 characterized in that said intraoral reference (2, 24, 25) comprises a permanent marker and/or a vial (30) containing the ink which can be used for the realization of indelible marks (25) formed directly on said anatomical portion (3) through holes on said rings (24). 13) Kit (5, 6, 9, 19) according to one or more of claims 9 to 12, characterized in that said anchoring device (5) comprises at least one arc (11) made of a deformable material.

14) Kit (5, 6, 9, 19) according to one or more of claims 9 to 13, characterized in that said anchoring device (5) comprises at least three fastening elements (16) associable with said anatomical portion (3).

15) Kit (5, 6, 9, 19) according to one or more of claims 9 to 14, characterized in that said anchoring device (5) comprises at least one holding element (12) of said extraoral reference element (6).

16) Method for the preparation of a reference system (1) for the implant dynamic navigation, comprising at least the following steps:

at least one step of preparation of at least one intraoral reference (2, 24, 25) in correspondence of at least one anatomical portion (3) to be treated inside the oral cavity (4) of a patient;

- at least one step of acquisition of digital data relating to the specific conformation of said at least one anatomical portion (3) and of the position of said at least one intraoral reference (2, 24, 25);

subsequently to a step of virtual planning of at least one implant to be installed in correspondence of said at least one anatomical portion (3) and prior to a step of implant dynamic navigation, at least one step of fixing to said anatomical portion (3) of at least one anchoring device (5) of an extraoral reference element (6);

characterized in that said step of preparation of at least one intraoral reference (2, 24, 25) comprises at least one of:

- the application in correspondence of at least three distinct points of said anatomical portion (3) of a compound (7, 8) comprising at least one tissue marker (7) and at least one contrast agent (8) trappable radiologically;

- the application of at least one adhesive strip (9) to said anatomical portion (3), said adhesive strip (9) having at least three separate and spaced apart containment seats for said contrast agent (8) trappable radiologically; - the application in correspondence of at least three distinct points of said anatomical portion (3) of a plurality of rings (24) composed at least in part of a contrast material trappable radiologically.

17) Method according to claim 16, characterized in that said step of preparation comprises the inoculation of said compound (7, 8) in correspondence of said three points of the anatomical portion (3) to be treated.

18) Method according to claim 16, characterized in that said step of preparation of the intraoral reference (2, 24, 25) comprises the realization of a plurality of indelible marks (25), using an appropriate permanent marker or by means of the realization of a tattoo point, through holes of said rings (24).

19) Method according to one or more of claims 16 to 18, characterized in that it comprises at least one step of probing of said at least one intraoral reference (2, 24, 25), so as to establish the three-dimensional spatial relationship of said extraoral reference (6) with respect to said at least one intraoral reference (2) and, therefore, with respect to said anatomical portion (2) of the patient to be treated.

20) Method according to one or more of claims 16 to 19, characterized in that, subsequently to said step of fixing of said anchoring device (5) and prior to said step of implant dynamic navigation, it comprises a step of calibration by means of deep probing of at least three bone points on said anatomical portion (3).

Description:
REFERENCE SYSTEM FOR DYNAMIC IMPLANT NAVIGATION AND KIT THEREFOR

Technical Field

The present invention relates to a reference system for the implant dynamic 5 navigation and related kit and method of preparation.

Background Art

With reference to the dental field, the use is known of suitable systems able to establish a correlation between the digital data relating to the specific conformation of an anatomical portion inside the mouth of a patient, detected by

10 scanning (e.g., by means of a CAT scan), and the spatial positioning of such anatomical portion determined using a dynamic detection system.

In the specific case of implantology, such known systems generally comprise a plastic or thermoplastic spoon, inside which is inserted or is connected an intraoral reference element (or fiducial), and to which are connected one or

15 more different extraoral reference elements (or fiducials).

The intraoral reference element is commonly made of metal and can consist, for example, of a known-geometry arc, of one or more suitably positioned spheres, spaced apart the one from the other, or of differently shaped elements.

The extraoral reference elements can consist of reflective spheres, discs or

20 drawings trappable with white light and can be localized and traced by means of a camera, in general of the type of an infrared or white light camera.

Alternatively, the extraoral reference elements can be made up of several infrared emitters suitably positioned and detectable by a special receiver.

During use, the intraoral fiducial is identified during CAT scan shooting, virtual

25 implant planning and assisted surgical navigation and is correlated to the anatomical area on which surgical navigation is to be implemented thanks to the mechanical interlocking which is obtained between the patient's residual set of teeth and the above-mentioned spoon.

Specifically, during surgical navigation, the correlation between the intra and 30 extraoral fiducials can be obtained by means of devices which ensure a predefined mechanical connection, fixed and stable between the two types of fiducials. Alternatively, such correlation can be obtained following the probing in sequence of each of the intraoral fiducials using a special handpiece connected to the navigation system, so as to establish the three-dimensional spatial relationship of the extraoral fiducial with respect to the intraoral fiducials and, therefore, with respect to the anatomical portion of the patient to be treated. Such known systems, nevertheless, have several drawbacks.

In fact, it is known that such systems do not work and, therefore, are not applicable in cases of total edentulism, as well as in programmed cases of immediate post-extraction loading of a complete arch, where for example the teeth still present have to be all extracted on the same day of implant surgery. Such systems are not applicable, furthermore, in cases where a terminal periodontitis puts at risk of inadvertent extraction some dental elements during the taking of an impression of the arch, during the intraoral thermoforming of the spoon and in many other clinical cases, e.g., in case of excessive discrepancy between the axes of the remaining teeth, low number and unfavorable position of the remaining teeth, the presence of unstable bridges or crowns, the presence of fixed orthodontics or post-treatment orthodontic splints, or the presence of a partially fractured tooth which has to be extracted and replaced with an implant.

To overcome these drawbacks, systems are known for edentulous patients which require the use of micro-screws for fixing the spoon containing the intraoral fiducial.

By way of example the document US 8,172,573 is mentioned, which describes a method for installing an implant in an at least partially edentulous patient, wherein the anchoring is made of several attachment elements to a patient's jaw bone and the fixing of a removable support having one or more fiducials to such attachment elements.

Such known solutions also have evident drawbacks however.

Specifically, the use of such known systems requires a surgical operation before the reading of data, e.g., by a CAT scan, for the virtual planning of the operation.

In fact, prior to the execution of the CAT scan, the fixing of one or more screws is necessary to support the intraoral reference element. This entails, therefore, the necessary performance of an invasive surgical operation on the patient long before the actual operation for the installation of the implants.

Description of the Invention

The main aim of the present invention is to provide a reference system for the implant dynamic navigation, which is able to allow for an efficient and accurate navigation also for edentulous patients or, in any case, for patients undergoing an extraction of all teeth of an arch and the simultaneous embedding of the implants.

Another object of the present invention is to provide a reference system for the implant dynamic navigation, which is able to allow for an efficient and precise execution of digitally programmable dental procedures.

Another object of the present invention is to provide a reference system for the implant dynamic navigation, which is not invasive for the patient from the surgical point of view and, in particular, which does not require invasive surgical operations on the patient prior to the actual operation of implant installation.

Another object of the present invention is to provide a reference system for the implant dynamic navigation that do not require the use of micro-screws or similar anchorage elements at the time of shooting the CAT scan.

Another object of the present invention is to provide a reference system for the implant dynamic navigation that do not require the use of devices produced by the orthodontist.

Another object of the present invention is to provide a reference system for the implant dynamic navigation which allows overcoming the mentioned drawbacks of the prior art within the ambit of a simple, rational, easy, effective to use as well as affordable solution.

The above mentioned objects are achieved by the present reference system for the implant dynamic navigation according to the characteristics described in claim 1.

The objects described above are also achieved by the present kit for the preparation of a reference system for the implant dynamic navigation according to the characteristics described in claim 9.

The objects described above are also achieved by the present method for the preparation of a reference system for the implant dynamic navigation according to the characteristics described in claim 16.

Brief Description of the Drawings

Other characteristics and advantages of the present invention will become better evident from the description of a preferred, but not exclusive, embodiment of a reference system for the implant dynamic navigation and related kit and method of preparation, illustrated by way of an indicative, yet non-limiting example, shown in the accompanying drawings, in which:

Figures 1 to 4 schematically illustrate the kit according to the invention;

Figures 5 to 8 schematically illustrate the system according to the invention and the related method of preparation;

Figures 9 to 15 schematically illustrate a further possible embodiment of the kit and of the system according to the invention and the related method of preparation.

Reference numeral 1 globally indicates in the illustrations a reference system usable for the implant dynamic navigation.

Specifically, the system 1 according to the invention is applicable to all patients, including edentulous patients and future edentulous patients, that is, all those patients who have to undergo the extraction of all the teeth of an arch and the simultaneous embedding of the implants.

Embodiments of the Invention

The system 1 according to the invention, once prepared inside the oral cavity 4 of a patient, comprises:

at least an intraoral reference 2 arranged in correspondence of at least one anatomical portion 3 to be treated inside the oral cavity 4 of the patient; at least an anchoring device 5 fixed to such anatomical portion 3;

and at least an extraoral reference 6 associated with the anchoring device 5. Advantageously, according to a possible embodiment, the aforementioned intraoral reference 2 is constituted by a compound applied in correspondence of at least three distinct points of the anatomical portion 3 to be treated, comprising:

at least one tissue marker 7 of the type of a marker visible on the gingiva for a predetermined time interval;

at least one contrast agent 8 trappable radiologically.

Preferably, the intraoral reference 2 of the system 1 is constituted by a compound 2 inoculated in correspondence of the above three points of the patient's anatomical portion 3 to be treated.

Therefore, the intraoral references 2 constituted by the at least three points made on the anatomical portion 3 to be treated are visible to the naked eye by the dental surgeon thanks to the presence of the tissue marker 7 and, also, are visible during a CAT scan thanks to the presence of the contrast agent 8.

Furthermore, advantageously, the intraoral references 2 so constituted by a compound inoculated in at least three points of the anatomical portion 3 to be treated are of simple and rapid application and absolutely not invasive for the patient.

Preferably, the tissue marker 7 used is of the type of a marker containing carbon.

For example, the tissue marker 7 can be constituted by carbon Sterop 4%. It is not ruled out, however, the use of a different type of tissue markers.

Furthermore, still according to a preferred embodiment, the contrast agent 8 used is of the type of a slow resorption barite or iodized gel (such as to guarantee a permanence even of several months).

For example, such contrast agent 8 can be constituted by an iodized gel of the Liopodol type or the like.

Also in this case it cannot however be ruled out the use of radiopaque substances of different type.

In an alternative embodiment, the intraoral reference 2 can be constituted by an adhesive strip 9, which is schematically illustrated in Figure 4, applied to the anatomical portion 3 and having at least three separate and spaced apart containment seats 10 for containing the contrast agent 8.

Once the adhesive strip 9 has been applied, the at least three seats 10 are arranged in correspondence of respective points of the anatomical portion 3. The anchoring device 5 comprises at least one arc 11 made of a deformable material and can be shaped so as to adapt to the specific anatomical portion 3 of the oral cavity 4 of the patient.

For example, the anchoring device 5 can be made of a metal (such as titanium, steel or the like), of a polymeric material or using different materials, including composites.

Furthermore, the anchoring device 5 has a holding element 12 for holding the extraoral reference 6, constituted by an elongated element, of fixed or variable geometry, which extends from a section of the arc 11 to the outside of the oral cavity 4.

Preferably, the extraoral reference 6 is constituted by reflective spheres, discs or drawings trappable with white light or, anyway, by objects locatable and traceable by means of a camera, preferably of the type of an infrared or white light camera.

For example, as schematically illustrated in the figures, the extraoral reference 6 can be constituted by a support 13 having a plurality of drawings 14 trappable with white light, by means of a suitable camera 15 of the navigation system 23. Alternatively, the extraoral reference 6 can comprise at least one infrared emitter detectable by means of a suitable receiver.

For example, the extraoral reference 6 can be constituted by a holding support of a plurality of infrared emitters suitably positioned and spaced apart from one another.

Furthermore, the anchoring device 5 comprises at least three fastening elements 16 associable with the anatomical portion 3 to be treated.

Preferably, such fastening elements 16 are constituted by rings sliding along respective sections of the arc 11 and fixed to the anatomical portion to be treated by means of suitable pins 17.

For example, such rings 16 can be associated sliding with the arc 11 by means of respective tubular elements 18 of small dimensions which are inserted axially sliding on respective sections of the arc itself.

Different embodiments of the anchoring device 5 cannot however be ruled out. For example, the arc 11 can have a greater number of fastening rings 16. Conveniently, moreover, the anchoring device can have a double arc with respective fastening elements 16.

In this case, once the anchoring device 5 has been positioned in the oral cavity 4 of the patient, the fastening elements 16 are intended to be fastened both on the palatine and lingual side.

Advantageously, the reference system 1 for the implant dynamic navigation can be prepared on the patient to be treated by means of a special kit, schematically illustrated in figures from 1 to 4.

In particular, as shown in figures from 1 to 3, the kit comprises:

- at least one medical injector device 19 containing the tissue marker 7 and the contrast agent 8 trappable radiologically, adapted to be inoculated in correspondence of at least three distinct points of the anatomical portion 3 to be treated inside the oral cavity 4 of the patient;

at least one anchoring device 5 fixable to the anatomical portion 3;

- at least one extraoral reference 6 associable with the anchoring device 5. Conveniently, alternatively or jointly to the medical injector device, the kit can comprise at least one adhesive strip 9, illustrated in Figure 4, applicable to the anatomical portion 3 to be treated and having at least three separate and spaced apart containment seats 10 for containing a contrast agent 8 trappable radiologically.

Conveniently, the medical injector device 19 can be constituted by a syringe comprising a first tank 20 containing the tissue marker 7 and a second tank 21 containing the contrast agent 8.

Conveniently, the syringe 19 can comprise a mixing element 22 arranged in correspondence of respective outlet openings of the first and second tank 20 and 21, and adapted to mix the tissue marker 7 and the contrast agent 8 during the inoculation, so as to obtain an inoculable compound.

Alternatively, the medical injector device 19 can be constituted by a syringe having a single tank containing a pre-mixed compound and comprising the tissue marker 7 and the contrast agent 8.

For example, the tissue marker 7 used is of the type of a marker containing carbon. For example, the tissue marker 7 can be constituted by carbon Sterop 4%.

The use of tissue markers 7 of different type cannot however be ruled out.

Furthermore, still according to a preferred embodiment, the contrast agent 8 used is of the type of a slow resorption barite or iodized gel (such as to guarantee a permanence even of several months).

Also in this case the use of radiopaque substances of different type cannot however be ruled out.

As schematically illustrated in Figure 1, the anchoring device 5 of the kit according the invention comprises at least one arc 11 made of a deformable material which can be shaped so as to adapt to the specific anatomical portion 3 of the oral cavity 4 of the patient.

Furthermore, the anchoring device 5 has a holding element 12 for holding the extraoral reference element 6, constituted by an elongated element, of fixed or variable geometry, which extends from a section of the arc 11 towards the outside of the oral cavity 4.

Preferably, the extraoral reference element 6 is constituted by reflective spheres, discs or drawings trappable with white light or, anyway, by objects locatable and traceable by means of a camera, preferably of the type of an infrared or white light camera.

For example, as schematically shown in Figure 2, the extraoral reference 6 can be constituted by a support 13 having a plurality of drawings 14 trappable with white light, by means of a suitable camera 15.

Alternatively, the extraoral reference 6 can comprise at least one infrared emitter detectable by means of a suitable receiver.

For example, the extraoral reference 6 can be constituted by a holding support of a plurality of infrared emitters suitably positioned and spaced apart from one another.

Furthermore, the anchoring device 5 comprises at least three fastening elements 16 associable with the anatomical portion 3 to be treated.

Preferably, such fastening elements 16 are constituted by rings sliding along respective sections of the arc 11 and fixable to the anatomical portion 3 to be treated by means of suitable pins 17. For example, such rings 16 can be associated sliding with the arc 11 by means of tubular elements 18 of small dimensions inserted axially sliding on respective sections of the arc itself.

Different embodiments of the anchoring device 5 cannot however be ruled out. For example, the arc 11 can have a greater number of fastening rings 16.

Conveniently, furthermore, the anchoring device 5 can have a double arc with respective fastening elements 16. In this case, once the anchoring device 5 has been positioned in the oral cavity 4 of the patient, the fastening elements 16 are intended to be fixed both on the palatine and lingual side.

Conveniently, the kit can comprise at least a probing device, not illustrated in the figures, for the calibration of the navigation system 23 by means of probing of at least three bone points on said anatomical portion 3.

For example, such a probing device can be constituted by a disposable milling cutter in the form of a needle.

The reference system 1 for the implant dynamic navigation can be prepared on the patient to be treated using the kit described above and using a predefined method.

In particular, this method is schematically illustrated in Figures 5 to 8 and comprises at least the following steps:

- at least one step of preparation of at least one intraoral reference 2 in correspondence of at least one anatomical portion 3 to be treated inside the oral cavity 4 of a patient (Figure 5);

at least one step of acquisition of digital data relating to the specific conformation of the anatomical portion 3 and of the position of such intraoral reference 2 (Figure 6);

subsequently to a step of virtual planning of at least one implant to be installed in correspondence of the anatomical portion, at least a step of fixing to the anatomical portion 3 of at least one anchoring device 5 of an extraoral reference element 6 (Figure 7).

Subsequently, an implant dynamic navigation phase is performed, guided by means of the system 1, for the installation of the implants (Figure 8).

In particular, the aforementioned step of acquisition can be performed by means of a computerized axial tomography (CAT).

Advantageously, the step of preparation of at least one intraoral reference 2 comprises the application in correspondence of at least three distinct points of the anatomical portion 3, namely at the mucogingival junction, of a compound comprising at least one tissue marker 7 visible on the gingiva for a predetermined time and at least a contrast agent 8 trappable radiologically.

Preferably, the aforementioned step of preparation of the intraoral reference 2 comprises the inoculation of the compound in correspondence of at least three points of the anatomical portion 3 to be treated.

Alternatively, this step of preparation of at least one intraoral reference 2 can provide for the application of at least one adhesive strip 9 in correspondence of the anatomical portion to be treated, in which the adhesive strip 9 has at least three distinct and spaced apart seats 11 containing the compound.

Preferably, the tissue marker 7 used is of the type of a marker containing carbon.

For example, the tissue marker 7 can be constituted by carbon Sterop 4%. The use of a different type of tissue markers cannot however be ruled out.

Furthermore, according to a preferred embodiment, the contrast agent 8 used is of the type of a slow resorption barite or iodized gel (such as to guarantee a permanence even of several months). Also in this case the use of radiopaque substances of different type cannot however be ruled out.

Advantageously, the application of the compound at the mucogingival junction ensures the impossibility of mobilization of the compound which by its nature tends to remain stable for several months in the tissues.

Moreover, the presence of iodine or other radiopaque compounds makes it trappable during the CAT scan, while the presence of carbon Sterop makes it visible for about three months as tattoo in a stable point of the gingiva.

It is specified that, in a considerably advantageous manner, the realization of the intraoral references 2 by means of the inoculation of the compound can be carried out very quickly. For example, the time taken for the realization of the intraoral references is comparable to the time commonly required for practicing a conventional local anesthesia inside the oral cavity. Moreover, the inoculation of the compound in correspondence of at least three points of the anatomical portion 3 does not constitute a surgically invasive operation for the patient.

Preferably, the intraoral references 2 must be at least three in order to allow for the identification of a reference plane.

The realization of a different number of intraoral references 2, with a different arrangement cannot however be ruled out.

For example, in order to ensure greater precision, the intraoral references 2 could be made in correspondence of five vestibular points, or in correspondence of three vestibular points and two palatine or lingual points.

Advantageously, therefore, the CAT scan can be performed without any device inserted inside the patient's mouth, thus obtaining a considerable simplification of the process and a minor discomfort for the patient. The radiopaque intraoral references 2 so made are therefore trapped when reading the CAT scan.

Subsequently, the virtual planning of an implant to be installed in correspondence of the anatomical portion 3 can be performed by means of a navigation system 23 of conventional type, having a suitably amended software so as to recognize the intraoral references 2 created by means of the inoculation of the compound.

The aforementioned step of fixing, illustrated in Figure 7, comprises the adaptation of the anchoring device 5 to the anatomical portion 3. Conveniently, such adaptation can be carried out shortly before the operation and the surgical navigation, in a few minutes.

The anchoring device 5 comprises at least one arc 11 made of a deformable material and can be shaped so as to adapt to the specific anatomical portion 3 of the oral cavity 4 of the patient.

Furthermore, the anchoring device 5 has a holding element 12 of the extraoral reference 6, constituted by an elongated element, of fixed or variable geometry, that extends from one section of the arc portion towards the outside of the oral cavity.

In particular, in case of using a holding element 12 of variable geometry, the method envisages a phase of probing in sequence of each of the intraoral references 2 by means of a handpiece connected to the navigation system 23, so as to establish the three-dimensional spatial relationship of the extraoral reference 6 with respect to the intraoral references 2 and, therefore, with respect to the anatomical portion 2 of the patient to be treated.

Preferably, the extraoral reference 6 is constituted by reflective spheres, discs or drawings trappable with white light or, anyway, by objects locatable and traceable by means of a camera, preferably of the type of an infrared or white light camera.

Alternatively, the extraoral reference 6 can be constituted by a holding support of a plurality of infrared emitters suitably positioned and spaced apart from one another.

Furthermore, the anchoring device 5 comprises at least three fastening elements 16 associable with the anatomical portion 3 to be treated.

Preferably, such fastening elements 16 are constituted by rings sliding along respective sections of the arc and fixable to the anatomical portion 3 to be treated by means of suitable pins 17.

For example, such rings 16 can be associated sliding with the arc 11 by means of tubular elements 18 of small dimensions inserted axially sliding on respective portions of the arc itself.

The fastening of the anchoring device 5 provides for the shift of each of the tubular elements 18 so as to position the rings 16 in correspondence of respective intraoral reference elements 2, the execution, under anesthetic, of small perforations of the gingiva and of the bone in correspondence of the intraoral references 2 and the fastening of the rings 16 by means of special pins 17.

For example, these pins 17 can be of the type conventionally used for fixing static surgical guides.

Conveniently, each of the tubular elements 18 has clamping means adapted to lock the tubular elements themselves on a section of the arc 11.

Conveniently, the anchoring device 5 can be glued to the anatomical portion 3 prior to the fastening by means of the pins 17. In this case, therefore, the insertion of the pins 17 is guided and simplified by the fixed position of the anchoring device 5.

Conveniently, the insertion of the pins can be guided by the use of the navigation system 23 and using a provisional reference applied to the patient's face.

In particular, this reference can be constituted by one or by the combination of: as far as the upper arch is concerned, special glasses worn by the patient, one or more adhesive tags applied on the patient's nose and cheekbones and, for the lower arch, a chin guard applied by means of an adhesive, an elastic sling fixed to the neck, or in another way to the lower portion of the patient's face.

In this case it is therefore possible to perform a further preliminary calibration by performing a surface probing with a suitable probing device of the navigation system 23 in correspondence of the intraoral references 2.

Therefore, following the fastening of the anchoring device 5 in at least three points the identification is obtained of the reference plane defined by the intraoral references 2 in the CAT scan and, therefore, it will be immediate to detect by means of the dynamic navigation system 23, the relative position of the extraoral reference.

Alternatively, the fastening of the anchoring device 5 can be made by perforating the gingiva and the bone in correspondence of different points with respect to the intraoral references 2.

In this case, the association between the intraoral references 2, and therefore between the collected data relating to the shape and to the position of the anatomical portion 3 to be treated, and the extraoral reference 6 is obtained subsequent to the fastening by performing a surface probing with a suitable probing device of the navigation system 23 in correspondence of the intraoral references 2.

Different embodiments of the anchoring device 5 cannot however be ruled out. For example, the arc 11 can have a greater number of fastening elements 16. Conveniently, furthermore, the anchoring device 5 can be equipped with a double arc having respective fastening elements 16. In this case, once the anchoring device 5 has been positioned inside the oral cavity 4 of the patient, the fastening elements 16 are intended to be fixed both on the palatine and lingual side.

Conveniently, subsequent to the fastening of the anchoring device 5 and prior to the implant dynamic navigation, the method can comprise a further step of calibration of the navigation system 23 by means of deep probing of at least three bone points on said anatomical portion 3.

In particular, such probing can be carried out by means of a special milling cutter in the form of a needle, possibly disposable, by perforating the gingiva on the vertical ridge of the intraoral references 2.

This allows therefore obtaining a better calibration of the navigation system 23, thus ensuring maximum accuracy.

With reference to a further alternative embodiment, schematically illustrated in figures from 9 to 15, the intraoral reference 24, 25 comprises a plurality of rings 24 applicable in correspondence of a plurality of distinct points of the anatomical portion 3 to be treated and composed at least in part of a contrast material trappable radiologically.

Preferably, the intraoral references 24, 25 comprise at least three separate rings 24 applicable in correspondence of respective three points of the anatomical portion 3 separate and spaced apart from one another.

In particular, the radiopaque rings 24 can be made of a polymeric material, e.g. of the type of polyterpene or the like, possibly admixed with barium or other radiopaque substance.

Alternatively, for example, the rings 24 can be made of a metal material, e.g. of the type of high atomic number titanium.

Advantageously, each of the rings 24 is fixable to the anatomical portion 3 by means of an adhesive layer distributed on one of the faces of the rings themselves.

For example, such adhesive layer can be constituted by a layer of cyanoacrylate. Advantageously, moreover, each intraoral reference 24, 25 can comprise a plurality of indelible marks 25 formed directly on the anatomical portion 3 through the holes of the rings 24.

For example, such indelible marks 25 can be made by means of a permanent marker 29 or by means of a tattoo point made with a special needle. Therefore, the rings 24 are visible both to the naked eye by the dental surgeon and during a CAT scan, while the eventual realization of the indelible marks 25 allows identifying the intraoral references even after the CAT scan and following the removal of the rings 24, in particular in the case in which the operation on the patient has to be made at a later time.

Moreover, advantageously, the intraoral references 24, 25 thus formed are of simple and rapid application and absolutely not invasive for the patient.

Different conformations of the rings 24 cannot however be ruled out, which can be constituted e.g. by perforated hemispheres.

Furthermore, with reference to a possible alternative embodiment, each ring 24 can be associated with the anatomical portion using a skin piercing. In this case, therefore, each ring 24 has at least a special appendix insertable under the gingiva.

The reference system 1 for the implant dynamic navigation thus formed can be prepared on the patient to be treated by means of a special kit, shown schematically in Figure 9.

In particular, such a kit comprises:

at least one applicator device 26 having a gripping handle 27 and at least one ending part 28 for housing a ring 24 adapted to be applied on the anatomical portion 3 to be treated;

at least one anchoring device 5 fixable to the anatomical portion 3;

at least one extraoral reference 6 associable with the anchoring device 5. Conveniently, the kit can further comprise a permanent marker 29 and/or a vial 30 containing the ink usable for the realization of indelible marks 25, together with a special needle.

Conveniently, the kit can comprise at least one probing device for the calibration of the navigation system 23 by means of probing of at least three bone points on said anatomical portion 3. For example, such a probing device can be constituted by a disposable milling cutter in the form of a needle.

The reference system 1 for implant dynamic navigation can be provided on the patient to be treated using the kit described above and by means of a predefined method. In particular, this method is schematically illustrated in Figures 10 to 14 and comprises at least the following steps:

at least one step of preparation of at least one intraoral reference 24, 25 in correspondence of at least one anatomical portion 3 to be treated inside the oral cavity 4 of a patient (Figure 10);

at least one step of acquisition of digital data relating to the specific conformation of the anatomical portion 3 and of the position of such intraoral reference 2 (Figure 11);

subsequently to a step of virtual planning of at least one implant to be installed in correspondence of the anatomical portion, at least one step of fixing to the anatomical portion 3 of at least one anchoring device 5 of an extraoral reference element 6 (Figure 13).

Subsequently, an implant dynamic navigation phase is carried out, guided by the system 1, for the installation of the implants (Figure 15).

In particular, the aforementioned step of acquisition can be performed by means of a computerized axial tomography (CAT).

Advantageously, the step of preparation of at least one intraoral reference 24, 25 comprises the application of the 24 rings in correspondence of at least three distinct points of the anatomical portion 3.

Moreover, in particular in the case in which the operation on the patient is not to be performed immediately after the CAT scan, but at a later time, the aforementioned step of preparation of the intraoral references 24, 25 comprises the realization of the indelible marks 25, using an appropriate permanent marker or through the realization of a tattoo point, through the holes of the rings 24 (Figure 12).

Therefore, the presence of the radiopaque rings 24 makes the intraoral references 24, 25 trappable during the CAT scan, while the presence of the indelible marks 25 makes them visible to the naked eye for a predetermined period, after the CAT scan.

It is noticed that, in a considerable advantageous manner, the realization of the intraoral references by means of the application of the rings 24 can be carried out very quickly. Moreover, the application of the rings 24 in at least three points of the anatomical portion 3 does not constitute a surgically invasive operation for the patient.

Advantageously, therefore, the CAT scan can be carried out without any device inserted within the patient's mouth, thus obtaining a considerable simplification of the process and a minor discomfort for the patient. The radiopaque rings 24 are then trapped when reading the CAT scan.

Subsequently, the virtual planning of an implant to be installed in correspondence of the anatomical portion 3 can be carried out by means of a navigation system 23 of the conventional type, having a suitably amended software so as to recognize the intraoral references 24, 25 created by means of the rings 24 and using the indelible marks 25.

The fastening of the anchoring device 5 provides for the shift of each of the tubular elements 18 as far as positioning the rings 16 in correspondence of respective points of the anatomical portion 3, the execution, under anesthestic, of small perforations of the gingiva and the bone in correspondence of such points and the fixing of the rings 16 by means of the pins 17.

Conveniently, as shown in Figure 13, the fastening of the anchoring device 5 by means of the pins 17 must not necessarily be carried out in correspondence of the indelible marks 25.

In this case, therefore, a step of probing in sequence of each of the indelible marks 25 by means of a handpiece 31 connected to the navigation system 23, so as to establish the three-dimensional spatial relationship of the extraoral reference 6 with respect to the intraoral references 2 and, therefore, with respect to the anatomical portion 2 of the patient to be treated.

Conveniently, the insertion of the pins can be guided by means of the use of the navigation system 23 and using a provisional reference applied to the patient's face.

In particular, in such case the method comprises a further preliminary calibration which provides for the application of a provisional reference consisting, e.g., of one or of the combination of:

as far as the upper arch is concerned, special glasses worn by the patient, one or more adhesive tags applied on the patient's nose and on the cheekbones, and

for the lower arch, a chin guard applied by means of an adhesive, an elastic sling fixed to the neck, or in another way to the lower portion of the patient's face.

This preliminary calibration provides, therefore, for a superficial probing with a suitable probing device of the navigation system 23 in correspondence of the intraoral references 2.

Conveniently, subsequent to the fastening of the anchoring device 5 and prior to the implant dynamic navigation, the method can comprise a further step of calibration of the navigation system 23 by means of deep probing of at least three bone points on said anatomical portion 3.

In particular, such probing can be carried out by means of a special milling cutter in the form of a needle, possibly disposable, by perforating the gingiva on the vertical ridge of the indelible marks 25.

This then allows obtaining a better calibration of the navigation system 23, ensuring maximum accuracy.

It has in practice been observed that the described invention achieves the intended objects.

In particular, the fact is underlined that the reference system for the implant dynamic navigation, thanks to the use of the specific intraoral references, is able to allow for an efficient and accurate navigation even for edentulous patients or, in any case, for patients undergoing an extraction of all the teeth of an arch and the simultaneous embedding of the implants.

The system and the method according to the invention, moreover, allow for an efficient and accurate navigation with reference to any guided navigation procedure in the dental field.

Furthermore, the system and the related method of preparation are not invasive for the patient from the surgical point of view.

Furthermore, the system and the related method of preparation does not require for the use of micro-screws upon shooting the CAT scan, or the use of specific devices produced by the orthodontist.